Curium

Curium Announces First Patients in Europe Injected With PYLCLARI® – an Innovative 18F-PSMA Pet Tracer Indicated in Patients With Prostate Cancer

Retrieved on: 
Giovedì, Novembre 16, 2023
Curium, European Commission, INN, Laboratory, Civil service commission, Patient, Nuclear medicine, European, Prostate cancer, PSMA, Cancer, Partnership, PET, Physician, Medical imaging

As a world leader in nuclear medicine, Curium is pleased to be improving the choice of diagnostic tools available to physicians in Greece to diagnose prostate cancer – ultimately for the benefit of prostate cancer patients.”

Key Points: 
  • As a world leader in nuclear medicine, Curium is pleased to be improving the choice of diagnostic tools available to physicians in Greece to diagnose prostate cancer – ultimately for the benefit of prostate cancer patients.”
    Savvas Thalasselis, Managing Director, SYN Innovation Laboratories SA commented: “Today’s announcement of the first dose of PYLCLARI® in Greece is an important milestone for the detection of prostate cancer, in particular for the primary staging of patients with high-risk prostate cancer prior to initial curative therapy.
  • Our long-term partnership with Curium has demonstrated our commitment to diagnosing patients with cancer, and we look forward to further supporting Curium with their future pipeline of diagnostic and therapeutic products.”
    Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI® in the European Union.
  • SYN Innovation Laboratories has been a partner with Curium since 2017, with exclusive manufacturing and distribution rights for Curium’s wide range of positron emission tomography products in Greece.
  • SYN Innovation Laboratories will manufacture PYLCLARI® at its facilities in Athens, Greece.

SHINE Technologies Names Harrie Buurlage Chief Commercial Officer of Isotopes

Retrieved on: 
Lunedì, Settembre 11, 2023
Curium, Pupa, NRG, Mallinckrodt, Nuclear Regulatory Commission, Business development, Radiation, Covidien, University, Cancer, Radiopharmaceutical, Ytterbium, Certification, Nuclear medicine, Patient, Shine Technologies, Physics, University of Groningen, Growth, Diagnosis, SHINE, Medical imaging, Isotope

JANESVILLE, Wis., Sept. 11, 2023 /PRNewswire/ -- SHINE Technologies, LLC, a next-generation fusion technology company, today announced that Harrie Buurlage has been named Chief Commercial Officer of Isotopes. Buurlage, who has been the General Manager of SHINE Europe since 2019, will now oversee all commercial aspects of SHINE's therapeutic and diagnostic medical isotope divisions. Supporting Buurlage in driving the growth of SHINE's medical isotope business will be Magdalena Brzezowska, a proven leader with extensive commercial experience in radiopharmaceuticals, who has been named Vice President of Sales and Business Development.

Key Points: 
  • JANESVILLE, Wis., Sept. 11, 2023 /PRNewswire/ -- SHINE Technologies, LLC, a next-generation fusion technology company, today announced that Harrie Buurlage has been named Chief Commercial Officer of Isotopes.
  • Buurlage, who has been the General Manager of SHINE Europe since 2019, will now oversee all commercial aspects of SHINE's therapeutic and diagnostic medical isotope divisions.
  • He was the Chief Operating Officer at NRG in the Netherlands, overseeing key nuclear installations, and the global director for nuclear manufacturing at Covidien USA, now Curium Pharma.
  • "SHINE is well-positioned to provide increased access to life-saving medicine, and I look forward to helping usher in the next era of medical isotope production," Buurlage said.

Curium Announces License and Development Agreement With Lantheus for AI-Based PSMA PET Software in Europe

Retrieved on: 
Martedì, Luglio 25, 2023
Curium, Partnership, CONDOR, PSMA, Deep learning, Clinical trial, European Directive on Traditional Herbal Medicinal Products, Cancer, McDonnell Douglas F/A-18 Hornet, Intelligence, PYTHON, PET, Committee, Nuclear medicine, Data, Patient, Artificial intelligence, European Medicines Agency, Diagnosis, AI, Prostate cancer, Medical imaging, European

The agreement builds on the existing prostate cancer PSMA-targeted PET imaging collaboration between Curium and Lantheus with an exclusive licensing and development agreement for AI-powered quantitative analysis and standardized reporting of PSMA PET/CT image assessments.

Key Points: 
  • The agreement builds on the existing prostate cancer PSMA-targeted PET imaging collaboration between Curium and Lantheus with an exclusive licensing and development agreement for AI-powered quantitative analysis and standardized reporting of PSMA PET/CT image assessments.
  • Under the terms of the agreement, EXINI’s deep learning platform will be tailored to meet the specific needs of the European market.
  • With the expanding treatment options in prostate cancer, including PSMA RLT, there is increasing demand for efficient, standardized quantitative assessment of PSMA disease burden.
  • Our partnership with Curium expands the pool of patient data informing our AI algorithm and enables more widespread access to our software.”

Curium Announces Publication of [18F]DCFPyL Versus [18F]Fluoromethylcholine Results From European Phase III Study (PYTHON Trial)

Retrieved on: 
Venerdì, Luglio 21, 2023
Curium, CONDOR, 18F, Prostate cancer, PSMA, Molecular imaging, European Directive on Traditional Herbal Medicinal Products, Cancer, PET, PYTHON, Google Images, Committee, Manuscript, Food and Drug Administration Amendments Act of 2007, MD, Patient, Master of Science, Chief Medical Officer (Ireland), PET/CT, European Medicines Agency, Phase, FDA, Recurrence, MD–PhD, European Journal, Food, European Journal of Nuclear Medicine and Molecular Imaging, Medical imaging, Nuclear medicine

PARIS, July 21, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [18F] piflufolastat ([18F]DCFPyL) versus [18F]fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer.

Key Points: 
  • PARIS, July 21, 2023 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today the publication of the results of its European, multicenter, prospective cross-over clinical trial which compared [18F] piflufolastat ([18F]DCFPyL) versus [18F]fluoromethylcholine PET/CT in patients with first biochemical recurrence of prostate cancer.
  • The results of the PYTHON trial were published online ahead of print in the European Journal of Nuclear Medicine and Molecular Imaging in June 2023.
  • The PYTHON Study (NCT04734184) was a Phase III, European, multicenter, prospective cross-over trial, to evaluate and compare the detection rates, impact on patient management and safety profiles of [18F]DCFPyL and [18F]fluoromethylcholine, in patients with first biochemical recurrence after initial definitive therapy with curative intent.
  • This study successfully met the primary endpoint.

Pharmaceutical Contract Manufacturing Market Report 2023: Patent Expiry and Increasing Demand for Generic Drugs Drives Growth - ResearchAndMarkets.com

Retrieved on: 
Lunedì, Giugno 26, 2023
Health, Pharmaceutical, Curium, Lundbeck, Roche, COVID-19, Emergent, Radiopharmaceutical, Ranibizumab, US, Acquisition, Patent, Mylan, Nuclear medicine, Recession, Safety, Fine chemical, Pharmaceutical industry, Droxidopa

The Pharmaceutical Contract Manufacturing Market Report 2023-2033 report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The Pharmaceutical Contract Manufacturing Market Report 2023-2033 report has been added to ResearchAndMarkets.com's offering.
  • Overall world revenue for the pharmaceutical contract manufacturing market will surpass US$145 billion in 2023.
  • This report tells you how the pharmaceutical contract manufacturing market will develop in the next 10 years, and in line with the variations in COVID-19 economic recession and bounce.
  • Discover qualitative analyses (including market dynamics, drivers, opportunities, restraints and challenges), cost structure, impact of rising pharmaceutical contract manufacturing prices and recent developments.

Curium Receives Positive CHMP Opinion of PYLCLARI® for Primary Staging of Patients With High-Risk PCa Prior to Initial Curative Therapy and to Localize Recurrence of PCa in Patients With a Suspected Recurrence Based on Increasing Serum Prostate-Specific A

Retrieved on: 
Venerdì, Maggio 26, 2023
Curium, CONDOR, Civil service commission, Prostate cancer, PSMA, European Medicines Agency, Committee for Medicinal Products for Human Use, Cancer, PET, Marketing, Committee, EMA, Nuclear medicine, Food and Drug Administration, Şakir, MD, Patient, Master of Science, Chief Medical Officer (Australia), INN, PCA, Phase, FDA, Recurrence, PSA, Food, European Commission, CHMP, Medical imaging, Piflufolastat F-18

Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, “This positive CHMP opinion for PYLCLARI® is an important step forward in our goal of redefining the experience of cancer through our trusted legacy in nuclear medicine.

Key Points: 
  • Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented, “This positive CHMP opinion for PYLCLARI® is an important step forward in our goal of redefining the experience of cancer through our trusted legacy in nuclear medicine.
  • Upon its approval, PYLCLARI® will become available across Europe to help patients along their prostate cancer journey.
  • We are very excited to bring PYLCLARI® to the market and contribute to improving the set of diagnostic tools available to better diagnose and monitor prostate cancer.
  • The CHMP’s positive opinion on PYLCLARI® will be referred to the European Commission, which will deliver a final decision in approximately two months.

NorthStar Medical Radioisotopes Announces Promotion of Jason Vinyard, MBA, MHA, to Vice President, Business Development, Therapeutic Technologies

Retrieved on: 
Mercoledì, Aprile 12, 2023
Biotechnology, Technology, Other Health, Health, Radiology, Pharmaceutical, Oncology, Health Technology, Other Technology, Medical Devices, Hardware, Curium, Business development, University of St. Francis, University, Health administration, Jacksonville State University, Radionuclide, Radiopharmaceutical, Cardinal, MBA, Multimedia, NorthStar, Nuclear medicine, Cardinal Health, Business administration, CDMO, Patient, Master of Business Administration, Knowledge, Growth, MHA, Actinium-225, Medical imaging, Management

NorthStar Medical Radioisotopes , LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic and medical imaging applications, has announced the promotion of Jason Vinyard, MBA, MHA, to Vice President, Business Development, Therapeutic Technologies.

Key Points: 
  • NorthStar Medical Radioisotopes , LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic and medical imaging applications, has announced the promotion of Jason Vinyard, MBA, MHA, to Vice President, Business Development, Therapeutic Technologies.
  • Mr. Vinyard, who has been with NorthStar since 2021, was previously Senior Director, Business Development, Therapeutic Technologies, for the Company.
  • In this new position, Mr. Vinyard will have responsibility to advance the successful commercialization and market implementation of therapeutic radioisotopes, including copper-67 (Cu-67) and non-carrier added (n.c.a.)
  • View the full release here: https://www.businesswire.com/news/home/20230412005134/en/
    NorthStar Medical Radioisotopes has promoted Jason Vinyard, MBA, MHA, to Vice President, Business Development, Therapeutic Technologies.

Curium Confirms No Supply Challenges in North America and Europe for its Eclipse Phase 3 Clinical Trial

Retrieved on: 
Martedì, Marzo 14, 2023
Curium, Cancer, MD, ECLIPSE, Patient, Master of Science, Nuclear medicine, Safety, Clinical trial, Chief medical informatics officer, Pharmaceutical industry

Since patient enrollment started in March 2022, the ECLIPSE Phase 3 trial has experienced reliable and uninterrupted supply of 177Lu-PSMA-I&T.

Key Points: 
  • Since patient enrollment started in March 2022, the ECLIPSE Phase 3 trial has experienced reliable and uninterrupted supply of 177Lu-PSMA-I&T.
  • Sakir Mutevelic, MD, MSc, Chief Medical Officer at Curium commented: “We continue to make strong progress in conducting our ECLIPSE Phase 3 clinical trial in North America and in Europe.
  • Reliability of clinical trial supply is extremely important for our patients and investigators, and we are pleased to confirm that our clinical trial supply with 177Lu-PSMA-I&T remains uninterrupted.
  • Curium is committed to the ECLIPSE clinical trial as well as our other ongoing clinical trials in oncology to further our mission of redefining the experience of cancer through our trusted legacy in nuclear medicine.” For more information about the ECLIPSE trial: www.eclipseclinicaltrial.org To locate a clinical trial site or contact Curium’s clinical trial: [email protected]

Delcath Announces Rotation of the Board of Directors Chairmanship; John R. Sylvester Appointed New Chairman as Company Prepares for US Commercial Launch

Retrieved on: 
Giovedì, Febbraio 16, 2023
Curium, Interventional oncology, SPECT, Boston Scientific, Patient, BTG, Liver, FOCUS, Writing, International, Growth, Chief commercial officer, Nursing, Management, Delcath Systems

In addition, Mr. Sylvester served as BTG plc's Chief Commercial Officer, leading both their Interventional Oncology and Interventional Vascular businesses, as well as BTG's Chief Development Officer accountable for Strategy, M&A and Market access.

Key Points: 
  • In addition, Mr. Sylvester served as BTG plc's Chief Commercial Officer, leading both their Interventional Oncology and Interventional Vascular businesses, as well as BTG's Chief Development Officer accountable for Strategy, M&A and Market access.
  • His role at BTG culminated with Boston Scientific's 2019 purchase of BTG for $4.2 billion.
  • Mr. Sylvester also built Biocompatibles International plc's Interventional Oncology business, which BTG purchased for £166.0 million in 2010.
  • Given John's strong commercial background in developing new markets, he is ideally suited to take the Board leadership role at this time," said Dr. Stoll.

Phlow Corp. Announces Formation of Business Advisory Board, New Board of Directors Appointment and Corporate President as Company Accelerates Towards Next Stage of Growth

Retrieved on: 
Giovedì, Febbraio 2, 2023
Curium, Kaleo, Johns Hopkins University, Culture, MD, BD, Biomedical engineering, Hovione, LivaNova, Esperies, Government, Wallace H. Coulter Department of Biomedical Engineering, Doctor of Philosophy, SK, EIT, Health care, Growth, Committee, Knowledge, Executive, Advisory board, Sentara Healthcare, Therapy, Pharmaceutical industry, Management, Phlow, Cambrex Corporation

Tim M. Mayleben, President of two private biopharma companies and board member of Marinus Pharma and Landos Biopharma.

Key Points: 
  • Tim M. Mayleben, President of two private biopharma companies and board member of Marinus Pharma and Landos Biopharma.
  • Previously, long-time CEO of Esperion and board member of LOXO, Vericel and a number of other public and private biopharmaceutical companies.
  • “I am thrilled to announce the formation of the Phlow Business Advisory Board.
  • As a result, and to drive excellence in execution and accelerate growth, Hackman was promoted from Chief Business Officer to President with Edwards remaining CEO.